Charles F. Schwartz

Off-Pump Coronary Artery Bypass Grafting Reduces Mortality and Stroke in Patients With Atheromatous Aortas: A Case Control Study

Background—Patients with severe atheromatous aortic disease (AAD) who undergo coronary artery bypass (CABG) have an increased risk of death and stroke. We hypothesized that in these high risk patients, off-pump coronary artery bypass (OPCAB) technique is associated with lower morbidity and mortality. Methods and Results—Between June 1993 and January 2002, 5737 patients undergoing CABG had routine intra-operative TEE with 913 (15.9%) found to have severe AAD in the aortic arch or ascending aorta. Of these, 211 patients who underwent OPCAB were matched with 211 on-pump CABG patients by age, ejection fraction, history of stroke, cerebrovascular disease, diabetes, renal disease, nonelective operation, and previous cardiac surgery. Hospital mortality was 11.4% (24/211) for on-pump CABG and 3.8% (8/211) for OPCAB (P =0.003). Multivariate analysis revealed that increased mortality was associated with on-pump CABG (P =0.001), acute MI (P =0.03), number of grafts (P =0.01), age (P =0.01), history of stroke or cerebrovascular disease (P =0.04), CHF (P =0.02), and peripheral vascular disease (P =0.03). Multivariate analysis showed that OPCAB technique was associated with decreased stroke (P =0.05). Freedom from any complication was 78.7% for on-pump CABG and 91.9% for OPCAB (P <0.001). At 36 month follow-up multivariate analysis revealed that increased mortality was associated with age (P =0.001), previous MI (P =0.03), and renal disease (P =0.04), whereas increased survival was associated with increased number of grafts (P =0.001) and OPCAB (P =0.01). Conclusions—OPCAB surgery in patients with severe AAD is associated with lower risk of death, stroke and complications and improved mid-term survival. Routine intra-operative TEE allows identification of these patients and directs choice of appropriate surgical technique.

A Decade of Minimally Invasive Mitral Repair: Long-Term Outcomes

BACKGROUND Short-term results with minimally invasive approaches for mitral valve repair in degenerative disease have been encouraging, with potential for diminishing blood loss and hospital length of stay. Little is known, however, about the long-term efficacy of this approach. This report analyzes a single institutions results over 12 years with minimally invasive mitral repair. METHODS Since 1986, 3,057 patients have undergone mitral valve repair; 1,601 patients had degenerative disease and are the subject of this report. Minimally invasive mitral repair was done in 1071 patients with a right anterior minithoracotomy and direct vision. Clinical and echocardiographic variables were entered prospectively into a database. RESULTS Hospital mortality was 2.2% for all patients (36 of 1601); 1.3% for isolated minimally invasive (9 of 712) and 1.3% (3 of 223) for isolated sternotomy mitral valve repair; and 3.6% (24 of 666) for valve repair plus a concomitant cardiac procedure. For isolated valve repair, 8-year freedom from reoperation was 91% +/- 2% for sternotomy and 95% +/- 1% for minimally invasive (p = 0.24), and 8-year freedom from reoperation or severe recurrent insufficiency was 90% +/- 2% for sternotomy and 93% +/- 1% for minimally invasive (p = 0.30). Eight-year freedom from all valve-related complications was 86% +/- 3% for sternotomy and 90% +/- 2% for minimally invasive (p = 0.14). CONCLUSIONS These data indicate that long-term outcomes after minimally invasive mitral repair are excellent and equivalent to results achieved with sternotomy. In view of previously published advantages of short-term morbidity, minimally invasive approaches to mitral valve surgery deserve expanded use.

Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)

OBJECTIVES we sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota). BACKGROUND FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies. METHODS RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping). RESULTS the study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019). CONCLUSIONS analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276).

Aortic valve replacement in patients with impaired ventricular function

BACKGROUND Patients with reduced ventricular function undergoing aortic valve replacement have increased operative risks, but the impact of valvular pathophysiology and other risk factors has not been clearly defined. METHODS From June 1992 through June 2002, 1,402 consecutive patients underwent isolated aortic valve surgery with or without coronary artery bypass grafting; of these patients, 416 had an ejection fraction less than 40% and are the subject of this report. These patients (mean age, 68.6) had severe stenosis (62.5%), severe regurgitation (30.3%), or mixed disease (7.2%). Aortic valve replacement plus coronary artery bypass grafting was performed in 48.4% of patients, and 27% had previous cardiac surgery. Follow-up included echocardiography and survival analysis. RESULTS Hospital mortality was 10.1% (42 of 416), with no difference between aortic stenosis (9.6%) and regurgitation (11.1%). Multivariate analysis revealed that age (p = 0.002) and renal disease (odds ratio = 4.2; 95% confidence interval, 1.9 to 9.3; p = 0.001) were independently associated predictors of mortality. Valvular pathophysiology had no impact on mortality. Peripheral vascular disease, multivessel coronary disease, and renal disease were associated risks for any postoperative complication. Peripheral vascular disease (odds ratio = 12.3, p = 0.02), history of cerebrovascular disease (odds ratio = 4.8, p = 0.038), and diabetes (odds ratio = 2.7, p = 0.04) were associated risks for stroke. The ejection fraction was more than 40% in 52% of the patients who had postoperative echocardiography (mean follow-up, 6 months). Actuarial survival revealed no difference between pathophysiologic groups. CONCLUSIONS Aortic valve surgery in patients with impaired ventricular function carries an acceptable operative risk that can be stratified by age and comorbidities. The type of valvular pathophysiology does not significantly affect mortality.

Impact of Moderate Functional Mitral Insufficiency in Patients Undergoing Surgical Revascularization

Background— Mild and moderate functional ischemic mitral insufficiency present at the time of surgical revascularization present clinical uncertainty. It is unclear whether the relatively poor outcomes in this cohort are dependent on valvular function or related to left ventricular dysfunction. The purpose of this study was to examine the early and late outcomes in patients with less-than-severe functional ischemic mitral insufficiency at the time of isolated coronary artery bypass grafting (CABG). Methods and Results— From 1996 through 2004, 2242 consecutive patients undergoing isolated CABG were identified as having none to moderate mitral regurgitation (MR) and no valve leaflet pathology. All of the patients at this single institution routinely had an intraoperative transesophageal echocardiography, prospectively quantified MR, and ejection fraction (EF). The New York State Cardiac Surgery Reporting System infrastructure was used to prospectively collect in-hospital patient variables and outcomes. Social Security Death Benefit Index was used to determine long-term survival. Odds ratio and significance (P value) are presented for each determined risk factor. There were 841 patients (37.5%) with no MR, 1137 (50.7%) with mild MR, and 264 (11.8%) with moderate MR. The patients with moderate MR were more likely to be older, female, and have more renal disease, previous MI, congestive heart failure, previous cardiac surgery, and lower EFs. Hospital mortality was independently and significantly associated with renal disease, decreasing EF, increasing age, previous cardiac operation, and cerebral vascular disease. Multivariable analysis revealed decreased survival with increasing age, previous operation, congestive heart failure, diabetes, nonelective operation, decreasing EF, and the presence of moderate MR (exp&bgr; = 1.49; P=0.007) and mild MR (exp&bgr; = 1.34; P=0.033). Conclusions— Independent of ventricular function, mild and moderate functional mitral insufficiency are associated with significantly decreased survival in patients undergoing CABG. Whether correction of moderate functional MR at the time of CABG improves outcome still needs to be determined.

Evolution of operative techniques and perfusion strategies for minimally invasive mitral valve repair

OBJECTIVE Perfusion strategies and operative techniques for minimally invasive mitral valve repair have evolved over time. During the past decade, our institutions approach has progressed from a port access platform with femoral perfusion to predominantly a central aortic cannulation through a right anterior minithoracotomy incision. We analyzed this institutional experience to evaluate the impact of approach on patient outcomes. METHODS Between 1995 and 2007, 1282 patients (mean age, 59.3 years; range, 18-99 years) underwent first-time, isolated mitral valve repair using a minimally invasive technique. Patient demographics included peripheral vascular disease (3.2%), chronic obstructive pulmonary disease (8.3%), atherosclerotic aorta (6.5%), cerebrovascular disease (4.3%), and ejection fraction less than 30% (4.3%). Retrograde perfusion was performed in 394 (30.7%) of all patients and endoaortic balloon occlusion in 373 (29.1%); the operative technique was a right anterior minithoracotomy in 1264 (98.6%) and left posterior minithoracotomy in 18 (1.4%). The etiology of mitral disease was degenerative in 73.2%, functional in 20.6%, and rheumatic in 2.4%. Data were collected prospectively using the New York State Cardiac Surgery Report System and a customized minimally invasive surgery data form. Logistic analysis was used to evaluate risk factors and outcomes; operative experience was divided into tertiles. RESULTS Overall hospital mortality was 2.0% (25/1282). Mortality was 1.1% (10/939) for patients with degenerative etiology and 0.4% (3/693) for patients younger than 70 years of age with degenerative valve disease. Risk factors for death were advanced age (P = .007), functional etiology (P = .010; odds ratio [OR] = 3.3), chronic obstructive pulmonary disease (P = .013; OR = 3.4), peripheral vascular disease (P = .014; OR = 4.2), and atherosclerotic aorta (P = .03; OR = 2.8). Logistic risk factors for neurologic events were advanced age (P = .02), retrograde perfusion (P = .001; OR = 3.8), and emergency procedure (P = .01; OR = 66.6). Interaction modeling revealed that the only significant risk factor for neurologic event was the use of retrograde perfusion in high-risk patients with aortic disease (P = .04; OR = 8.5). Analysis of successive tertiles during this 12-year experience revealed a significant decrease in the use of retrograde arterial perfusion (89.6%, 10.4%, and 0.0%; P < .001) and endoaortic balloon occlusion (89.3%, 10.7%, and 0%; P < .001). The overall frequency of postoperative neurologic events was 2.3% (30/1282) and decreased from 4.7% in the first tertile to 1.2% in the second and third tertiles (P < .001). CONCLUSIONS Central aortic cannulation through a right anterior minithoracotomy for mitral valve repair allows excellent outcomes in patients with a broad spectrum of comorbidities and has become our preferred approach for most patients undergoing mitral valve repair. Retrograde arterial perfusion is associated with an increased risk of stroke in patients with severe peripheral vascular disease and should be reserved for select patients without significant atherosclerosis.

Minimally Invasive Reoperative Isolated Valve Surgery: Early and Mid-Term Results

Abstract  Objective: Minimally invasive, nonsternotomy approaches for valve procedures may reduce the risks associated with cardiac surgery after prior sternotomy and may improve outcomes. We analyzed our institutional experience to test this hypothesis. Methods: Between 1995 and 2002, 498 patients with previous cardiac operations via sternotomy underwent isolated valve surgery: 337 via median sternotomy (aortic = 160; mitral = 177) and 161 via mini‐thoracotomy (aortic = 61; mitral = 100). Data were collected prospectively using the New York State Cardiac Surgery Report Form. Results: Preoperative incidences of congestive heart failure, renal disease, and nonelective procedures were higher in the sternotomy group. Hospital mortality was significantly lower with the minimally invasive approach, 5.6% (9/161) versus 11.3% (38/337) (univariate, p = 0.04). However, multivariate analysis (odds ratio: 95% confidence intervals, p value) revealed that chronic obstructive pulmonary disease (6.6: 1.4 to 3.1, p = 0.001), renal disease (4.1: 1.52 to 11.2, p = 0.01), cerebrovascular disease (2.2: 1.03 to 4.78, p = 0.04), and ejection faction <30% (1.5: 0.96 to 5.5, p = 0.06) were associated with increased mortality. While mean bypass time, cross‐clamp times, and stroke rates were comparable between groups, patients undergoing minimally invasive valve surgery had no deep wound infections (0% vs 2.4%, p = 0.05), less need for blood products (p = 0.02), and shorter hospital stays (p = 0.009). Five‐year survival was higher with minimally invasive techniques as compared to a sternotomy approach (92.4 ± 2% and 86.0 ± 2%, respectively, p = 0.08). Conclusions: Reoperative valve surgery can be safely performed using a nonsternotomy, minimally invasive approach, with at least equal mortality, less hospital morbidity, decreased hospital length of stay, and slightly favorable mid‐term survival as compared to sternotomy.

Minimally Invasive Aortic Valve Surgery in the Elderly: A Case-Control Study

Introduction—Although minimally invasive aortic valve surgery (MIAVR) is performed in many centers, few studies have compared its results to a standard sternotomy (SS) approach. We assessed the hypothesis that, when compared with SS in the elderly population, MIAVR has similar morbidity and mortality and allows faster hospital recovery. Methods and Results—From January 1995 through February 2002, 515 patients over age 65 underwent isolated aortic valve replacement. Using data gathered prospectively, 189 MIAVR patients were matched with 189 SS patients by age, ventricular function, valvular pathology, urgency of operation, diabetes, previous cardiac surgery, renal disease, and history of stroke. In each group, 56.1% of patients underwent non-elective procedures, and 28% were ≥80 years old. Hospital mortality (6.9%) and freedom from postoperative morbidity (82.5% versus 81.5%, P =0.79) were similar. Multivariate analysis revealed that urgent procedures [Odds Ratio (OR)=3.97; P =0.03], congestive heart failure (OR=3.94; P =0.03), and ejection fraction <30% (OR=4.16; P =0.03) were significant predictors of hospital mortality. Prolonged length of stay was associated with age (P =0.05), preoperative stroke (OR=3.5, P =0.001), CHF (OR=2.2, P =0.004), and sternotomy approach (OR=2.3, P =0.002) by multivariate analysis. More MIAVR patients were discharged home (52.6% versus 38.6%, P =0.03) rather than to rehabilitation facilities. Three year actuarial survival revealed no difference between groups. Conclusions—Minimally invasive aortic valve surgery is safe in elderly patients, with morbidity and mortality comparable to sternotomy approach. The shorter hospital stay and greater percentage of patients discharged home after MIAVR reflect enhanced recovery with this technique.

Retrograde Arterial Perfusion, Not Incision Location, Significantly Increases the Risk of Stroke in Reoperative Mitral Valve Procedures

BACKGROUND A recent report suggested that a thoracotomy approach for reoperative mitral valve (MV) procedures was associated with an equivalent mortality and an unacceptable risk of stroke. We assessed these outcomes in a single institutions experience. METHODS From 1992 through 2007, 905 patients underwent reoperative MV procedures. The approach was a median sternotomy in 612 (67.6%), right anterior thoracotomy in 242 (26.7%), and left posterior thoracotomy in 51 (5.6%). Concomitant procedures in 411 patients (67.6%) included aortic procedures in 189, tricuspid procedures in 170, and coronary artery bypass grafting in 90. Hypothermic fibrillation was used in 65 patients. Logistic analysis was used to analyze risk factors and outcomes. RESULTS Overall mortality was 12.7% (115 of 905), 6.7% (25 of 371) for first time isolated MV reoperations, and 10.1% (50 of 494) for all isolated MV operations. Overall incidence of stroke was 3.8% (34 of 905); 10.9% (9 of 82) with retrograde arterial perfusion and 3.0% (25 of 824) with central aortic cannulation (p < 0.001). For isolated MV reoperations, the incidence of stroke was 4.3% (21 of 494): 2.9% (7 of 241) for antegrade perfusion and 5.5% (14 of 253) for retrograde perfusion (p = 0.15). Risk factors for death were age (p < 0.001), renal failure (p < 0.01), tricuspid valve disease (p < 0.001), chronic obstructive pulmonary disease (odds ratio [OR], 2.9; 95% confidence interval [CI], 1.8 to 4.9; p < 0.001), emergency procedure (OR, 2.9; 95% CI, 1.2 to 6.9; p = 0.02), and ejection fraction less than 0.30 (OR, 1.9; 95% CI, 1.1 to 3.3, p = 0.018). Risk factors for stroke were retrograde perfusion (OR, 4.4; 95% CI, 1.8 to 10.3; p < 0.01) and ejection fraction below 0.30 (OR, 2.1; 95% CI, 0.9 to 5.0; p = 0.09). CONCLUSIONS The incidence of stroke in reoperative MV operations is associated with perfusion strategies, not with the incisional approach. Reoperative sternotomy and minithoracotomy with central cannulation are both useful for reoperative MV procedures and are associated with low stroke rates.

Outcomes of coronary artery bypass grafting and reduction annuloplasty for functional ischemic mitral regurgitation: A prospective multicenter study (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)

OBJECTIVE Functional ischemic mitral regurgitation is a complication of ventricular remodeling; standard therapy is reduction annuloplasty and coronary artery bypass grafting. Unfortunately, outcomes are retrospective and contradictory. We report a multicenter study that documents the outcomes of reduction annuloplasty for functional ischemic mitral regurgitation. METHODS Twenty-one centers randomized 75 patients to the coronary artery bypass grafting + reduction annuloplasty subgroup that was the control arm of the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve trial. Entry criteria included patients requiring revascularization, patients with severe or symptomatic moderate functional ischemic mitral regurgitation, an ejection fraction 25% or greater, a left ventricular end-diastolic dimension 7.0 cm or less, and more than 30 days since acute myocardial infarction. All echocardiograms were independently scored by a core laboratory. Reduction annuloplasty was achieved by device annuloplasty. Two patients underwent immediate intraoperative conversion to a valve replacement because reduction annuloplasty was unable to correct mitral regurgitation; as-treated results are presented. RESULTS Thirty-day mortality was 4.1% (3/73). Patients received an average of 2.8 bypass grafts. Mean follow-up was 24.6 months. Mitral regurgitation was reduced from 2.6 ± 0.8 preoperatively to 0.3 ± 0.6 at 2 years. Freedom from death or valve reoperation was 78% ± 5% at 2 years. There was significant improvement in ejection fraction and New York Heart Association class with reduction of left ventricular end-diastolic dimension. Cox regression analyses suggested that increasing age (P = .001; hazard ratio, 1.16 per year; 95% confidence interval, 1.06-1.26) and renal disease (P = .018; hazard ratio, 3.48; 95% confidence interval, 1.25-9.72) were associated with decreased survival. CONCLUSIONS Coronary artery bypass grafting + reduction annuloplasty for functional ischemic mitral regurgitation predictably reduces mitral regurgitation and relieves symptoms. This treatment of moderate to severe mitral regurgitation is associated with improved indices of ventricular function, improved New York Heart Association class, and excellent freedom from recurrent mitral insufficiency. Although long-term prognosis remains guarded, this multicenter study delineates the intermediate-term benefits of such an approach.